NCT06309667

Brief Summary

This is a Phase 1, first-in-human (FIH), randomized, double-blind, placebo-controlled, combined single (Part A) multiple (Part B, C) ascending dose, phase 1 study to investigate the safety, tolerability and pharmacokinetic and pharmacodynamics following subcutaneous injections of PG-102(MG12) in healthy adult participants. This study will be conducted in 3 Parts (Part A, B and C), with up to 5 cohorts in each part.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Mar 2024

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2024

Completed
19 days until next milestone

Study Start

First participant enrolled

March 4, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 13, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2025

Completed
Last Updated

May 6, 2025

Status Verified

May 1, 2025

Enrollment Period

11 months

First QC Date

February 14, 2024

Last Update Submit

May 5, 2025

Conditions

HealthyOverweight

Outcome Measures

Primary Outcomes (8)

  • Number of participants with treatment-emergent adverse events (TEAEs) for Part A

    Number of participants with treatment-emergent adverse events (TEAEs)

    Baseline to Day 29

  • Number of participants with treatment-emergent adverse events (TEAEs) for Part B

    Number of participants with treatment-emergent adverse events (TEAEs)

    Baseline to Day 57

  • Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0 for Part A

    Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0

    Baseline to Day 29

  • Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0 for Part B

    Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0

    Baseline to Day 57

  • Number of participants with clinically significant abnormalities in vital signs for Part A

    Blood pressure (mmHg), Respiration (breathing) rate per minute, Body temperature (Celsius)

    Baseline to Day 29

  • Number of participants with clinically significant abnormalities in vital signs for Part B

    Blood pressure (mmHg), Respiration (breathing) rate per minute, Body temperature (Celsius)

    Baseline to Day 57

  • Number of participants with clinically significant abnormalities in 12-lead ECGs for Part A

    Ventricular rate (bpm), PR interval (msec), QRSD (msec), QT (msec), QTc (msec)

    Baseline to Day 29

  • Number of participants with clinically significant abnormalities in 12-lead ECGs for Part B

    Ventricular rate (bpm), PR interval (msec), QRSD (msec), QT (msec), QTc (msec)

    Baseline to Day 57

Secondary Outcomes (10)

  • Maximum plasma concentration (Cmax) for Part A

    Baseline to Day 29

  • Maximum plasma concentration (Cmax) for Part B

    Baseline to Day 57

  • Time to maximum plasma concentration (tmax) for Part A

    Baseline to Day 29

  • Time to maximum plasma concentration (tmax) for Part B

    Baseline to Day 57

  • Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t) for Part A

    Baseline to Day 29

  • +5 more secondary outcomes

Study Arms (11)

Cohort A1 - Single Ascending Dose

EXPERIMENTAL

PG-102(MG12) Dose 1 (N=8) Subcutaneous injection

Drug: PG-102(MG12)Other: Placebo

Cohort A2 - Single Ascending Dose

EXPERIMENTAL

PG-102(MG12) Dose 2 (N=8) Subcutaneous injection

Drug: PG-102(MG12)Other: Placebo

Cohort A3 - Single Ascending Dose

EXPERIMENTAL

PG-102(MG12) Dose 3 (N=8) Subcutaneous injection

Drug: PG-102(MG12)Other: Placebo

Cohort A4 - Single Ascending Dose

EXPERIMENTAL

PG-102(MG12) Dose 4 (N=8) Subcutaneous injection

Drug: PG-102(MG12)Other: Placebo

Cohort A5 - Multiple Ascending Dose

EXPERIMENTAL

PG-102(MG12) Dose 5 (N=8) Subcutaneous injection

Drug: PG-102(MG12)Other: Placebo

Cohort B1 - Multiple Ascending Dose

EXPERIMENTAL

PG-102(MG12) Dose 1 (N=6) Subcutaneous injection

Drug: PG-102(MG12)Other: Placebo

Cohort B2 - Multiple Ascending Dose

EXPERIMENTAL

PG-102(MG12) Dose 1\~5 (N=6) Subcutaneous injection

Drug: PG-102(MG12)Other: Placebo

Cohort B3 - Multiple Ascending Dose

EXPERIMENTAL

PG-102(MG12) Dose 1\~5 (N=6) Subcutaneous injection

Drug: PG-102(MG12)Other: Placebo

Cohort S - Multiple Ascending Dose

EXPERIMENTAL

PG-102(MG12) Optimal Dose (N=6) Subcutaneous injection

Drug: PG-102(MG12)Other: Placebo

Cohort C1 - Multiple Ascending Dose

EXPERIMENTAL

PG-102(MG12) Dose 1 (N=12) Subcutaneous injection

Drug: PG-102(MG12)Other: Placebo

Cohort C2 - Multiple Ascending Dose

EXPERIMENTAL

PG-102(MG12) Dose 1 (N=12) Subcutaneous injection

Drug: PG-102(MG12)Other: Placebo

Interventions

PG-102(MG12)DRUG

GLP-1 and GLP-2 fusion protein

Cohort A1 - Single Ascending DoseCohort A2 - Single Ascending DoseCohort A3 - Single Ascending DoseCohort A4 - Single Ascending DoseCohort A5 - Multiple Ascending DoseCohort B1 - Multiple Ascending DoseCohort B2 - Multiple Ascending DoseCohort B3 - Multiple Ascending DoseCohort C1 - Multiple Ascending DoseCohort C2 - Multiple Ascending DoseCohort S - Multiple Ascending Dose
PlaceboOTHER

Placebo drug of PG-102(MG12)

Cohort A1 - Single Ascending DoseCohort A2 - Single Ascending DoseCohort A3 - Single Ascending DoseCohort A4 - Single Ascending DoseCohort A5 - Multiple Ascending DoseCohort B1 - Multiple Ascending DoseCohort B2 - Multiple Ascending DoseCohort B3 - Multiple Ascending DoseCohort C1 - Multiple Ascending DoseCohort C2 - Multiple Ascending DoseCohort S - Multiple Ascending Dose

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female participants, aged 18 to 65 years inclusive at the time of signing informed consent
  • Body mass index (BMI) of 18 to 30kg/m2 (inclusive) for Part A, Body mass index (BMI) of 25 to 30kg/m2 (inclusive) for Part B and Body mass index (BMI) 30 kg/m² or higher for Part C

You may not qualify if:

  • History of administration of prescription drugs, herbal medicines, over-the-counter drugs, or vitamin supplements within 10 days prior to the study or history of the following drugs and/or other foods within 90 days prior to screening:
  • Drugs that affect body weight (such as obesity medications, psychiatric drugs, beta blockers, diuretics, contraceptives, female hormones, proton-pump inhibitors (PPIs), H2 receptor antagonists, health functional foods/supplements, and formulas designed for weight control).
  • Drugs that have the potential to impact blood sugar, liver fat, and intestinal microorganisms (including GLP-1 receptor agonists, DPP-4 inhibitors, SGLT-2 inhibitors, thiazolidinediones (TZDs), fish oil, polyunsaturated fatty acids (PUFA), and ursodeoxycholic acid (UDCA)), as well as individuals who are currently using insulin.
  • History of gastrointestinal diseases (Crohn's disease, ulcers, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (excluding simple appendectomy or hernia surgery) that may affect the absorption of clinical trial drugs.
  • History of acute proliferative retinopathy or maculopathy, severe gastroparesis, and/or severe neuropathy.
  • History of surgical treatment for obesity within 2 years (example: bariatric surgery, gastric banding etc) or gastrointestinal procedures for weight loss (including LAP-BAND®), or uncontrolled gastrointestinal disorders at Screening (e.g., peptic ulcer, gastroesophageal reflux disease).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University Seoul St.Mary Hospital,

Seocho, Seoul, 06591, South Korea

Location

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Seunghoon Han, MD

    Catholic University Seoul St.Mary Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2024

First Posted

March 13, 2024

Study Start

March 4, 2024

Primary Completion

February 5, 2025

Study Completion

February 5, 2025

Last Updated

May 6, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)